Contact information

Type

Primary contact

ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RPC178

Study information

Scientific title

Acronym

Study hypothesis

The present study is pivotal, designed as a non-inferiority trial to evaluate the immunogenicity and the safety of one dose of 10 µg of PsA-TT vaccine. Immunological memory and persistence of antibodies induced by a single intramuscular injection of the study vaccine will also be evaluated. The immunogenicity will be assessed against that of a licensed meningococcal polysaccharide ACYW vaccine. The three-group design will allow comparison of the PsA-TT vaccine (study vaccine group) safety profile with that of two licensed vaccines: the meningococcal ACYW tetravalent polysaccharide vaccine (Mencevax - reference vaccine group), and the Hib-conjugate vaccine (Hiberix - control vaccine group). The booster study is expected to provide evidence that the PsA-TT conjugate vaccine is able to prime immunological memory. Antibody persistence will be evaluated at eight months (i.e. before the booster dose), one year and two years after the first dose.

Ethics approval

This protocol has been approved by the following institutions:1. Human Subjects Protection Committee at PATH, USA2. University of Maryland Baltimore Institutional Review Board (IRB), USA3. Comité d'Ethique de la Faculté de Médecine, de Pharmacie et d'Odonto-Stomatologie, Mali4. Medical Research Council Scientific Coordinating Committee, The Gambia5. Medical Research Council Gambia Government Ethics Committee, The Gambia 6. World Health Organization (WHO) Research Ethics Review Committee

Study design

A phase II, observer-blind, randomised, active controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Meningococcal A disease

Intervention

The intervention is vaccination at day zero of one of the three vaccines: study vaccine, reference vaccine (Mencevax) or control vaccine (Hiberix) , followed by a booster vaccination 32 weeks later with one of the three vaccines, study vaccine, reference vaccine (1/5th of a dose) or control vaccine. Subjects will be randomised in a 1:1:1 ratio.

Program for Appropriate Technology in Health (PATH) 1455 NW Leary Way Seattle WA 98107 United States of America Sponsor website: http://www.path.org

This trial was accepted and approved by the ISRCTN on the 18th September, but assigned an ISRCTN on the 21/09/06 due to technical reasons. The date of the ISRCTN assignment should be taken as the 18th September 2006.

Intervention type

Drug

Phase

Phase II

Drug names

Primary outcome measures

The percentage of subjects who show a seroconversion for anti-Meningococcal Polysaccharide A (MenPsA) antibodies, i.e. a four-fold increase in post-immunisation serum titre with respect to pre-immunisation serum titre, at 28 days after a single vaccine dose, as measured by rank Signaling Block Age (rSBA) assay.

Secondary outcome measures

1. The percentage of subjects with local and systemic adverse events, including solicited adverse reactions and events, and Serious Adverse Events (SAEs), as measured at four and 28 days after the primary vaccination (reactogenicity and short-term safety)2. The percentage of subjects with local and systemic adverse events, including solicited adverse reactions and events, and SAEs, as measured at four and 28 days after the booster vaccination (reactogenicity and short-term safety)3. The percentage of subjects who show a seroconversion for anti-MenPsA total Immunoglobulin G (IgG), i.e. a two-fold increase in post-immunisation serum concentration with respect to pre-immunisation serum concentration, at 28 days after a single vaccine dose, as measured by the Enzyme-Linked ImmunoadSorbent Assay (ELISA). The percentage of subjects with a four-fold increase in post-immunisation serum concentration with respect to pre-immunisation serum concentration will be also considered.

Overall trial start date

28/08/2006

Overall trial end date

28/11/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 12 to 23 months of age (both included)2. Written informed consent obtained from the mother, father, or guardian of the child3. Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator4. Mother, father, or guardian capable and willing to bring their child or to receive home visits for their child for all follow-up visits5. Residence in the study area6. Fully vaccinated according to local Expanded Program on Immunisation (EPI) schedule

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

600

Participant exclusion criteria

1. Previous vaccination against serogroup A Neisseria meningitidis2. Known exposure to serogroup A Neisseria meningitidis during the three previous months3. History of allergic disease or known hypersensitivity to any component of the three study vaccines4. History of Serious Adverse Reactions (SAR) following administration of vaccines included in the local program of immunization5. Administration of any other vaccine within 60 days prior to administration of study vaccines or planned vaccination during the first four weeks after the study vaccination6. Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines7. Administration of immunoglobulins and/or any blood products since birth or planned administration during the vaccine period8. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents since birth (including systemic or inhaled corticosteroids, this means prednisone or equivalent, 0.5 mg/kg/day [topical steroids are allowed])9. A family history of congenital or hereditary immunodeficiency10. History of meningitis or seizures or any neurological disorder11. Major congenital defects or serious chronic illness, including malnutrition (as per investigator's judgment)12. Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever) is a temporary exclusion13. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination or laboratory tests, which in the opinion of the investigator, might interfere with the study objectives14. Any condition or criteria that in the opinion of the investigator might compromise the well being of the subject or the compliance with study procedures or interfere with the outcome of the study15. Non-residence in the study area or intent to move out within one year